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Trial registered on ANZCTR


Registration number
ACTRN12622000722796
Ethics application status
Approved
Date submitted
18/04/2022
Date registered
19/05/2022
Date last updated
14/06/2023
Date data sharing statement initially provided
19/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Social Humanoid Robot to Deliver Cognitive Flexibility Training for Healthy Adults
Scientific title
An Investigation of Feasibility for A Social Humanoid Robot to Deliver Emotion Regulation Training and its Effect on Cognitive Flexibility in Healthy Adults
Secondary ID [1] 306877 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Flexibility 325779 0
Condition category
Condition code
Mental Health 323118 323118 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Depression and anxiety symptoms often are exacerbated by unhelpful thoughts and beliefs. Identifying unhelpful, automatic thoughts and instead holding alternate thoughts can be termed cognitive flexibility.

This trial is a single-arm, pilot project to evaluate whether a humanoid social robot can deliver a digitised version of an intervention that can help to teach people skills related to cognitive flexibility, and to improve their use of cognitive flexibility on completion of the session. This trial aims to evaluate the feasibility, preliminary effectiveness, and delivery method of a novel robot-delivered intervention.

The use of a humanoid social robot offers a new delivery mechanism for well-established cognitive flexibility interventions. Potential significance includes the capacity to help young adults to improve cognitive flexibility with the secondary aim to potentially reduce the prevalence of thought patterns that can lead to symptoms of depression and anxiety. The novel robot delivery method may assist with scaling and with people who are uncomfortable seeking support from a counsellor or psychologist.

Participants will complete online questionnaires at Baseline and Post-Intervention (2-weeks), and complete a 45-minute intervention session led by the Pepper robot, which will deliver an adapted version of a psychotherapeutic treatment related to cognitive flexibility through the Pepper robot, which is based on Cognitive Behavioural Therapy. This intervention will be delivered both as an in-person test, as well as remote/online as an alterative to those who are unable to attend the in-person session. Participants will engage with the intervention by progressing through the content steps provided during the session.
Intervention code [1] 323215 0
Behaviour
Intervention code [2] 323596 0
Treatment: Other
Comparator / control treatment
There is no comparator or control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330886 0
A primary outcome is to determine the impact on specific types of unhelpful, inflexible thoughts such as catastrophizing. Selected subscales from the Cognitive Emotion Regulation Questionnaire (CERQ) will be used to measure specific types of unhelpful, inflexible thoughts.
Timepoint [1] 330886 0
Baseline, post-intervention (2-weeks).
Secondary outcome [1] 407923 0
A secondary outcome is to determine the effect on overall emotion regulation difficulty in participants from baseline to post intervention. Difficulties in Emotion Regulation Scale (DERS) is a published validated measure of overall emotion regulation difficulty.
Timepoint [1] 407923 0
Baseline, post-intervention (2-weeks).
Secondary outcome [2] 407924 0
A secondary outcome is to determine if cognitive flexibility changes in participants from baseline to post intervention. A secondary outcome will be measured by capturing changes on the UP Cognitive Skills Questionnaire (UPCSQ). The UPCSQ is a published validated measure of cognitive skills, including to assess cognitive flexibility.
Timepoint [2] 407924 0
Baseline, post-intervention (2-weeks).
Secondary outcome [3] 408801 0
A secondary outcome is to determine if depression symptoms change from baseline to post intervention. A secondary outcome will be measured by capturing changes on depression symptoms from the PROMIS Depression CATs, which is a published and validated symptom measure.

Timepoint [3] 408801 0
Baseline, post-intervention (2-weeks).
Secondary outcome [4] 409686 0
A secondary outcome is to determine if anxiety symptoms change from baseline to post intervention. A secondary outcome will be measured by capturing changes on anxiety symptoms from the PROMIS Anxiety CATs, which is a published and validated symptom measure.
Timepoint [4] 409686 0
Baseline, post-intervention (2-weeks).

Eligibility
Key inclusion criteria
At least 18 years of age or older and currently enrolled as a university student.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they: (a) are not a Monash university student, (b) have severe depression or anxiety symptoms (T Scores equal to 70 on the Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS Depression CAT or PROMIS Anxiety CAT, and (c) are under 18 years old.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Demographics and feasibility will be assessed using descriptive statistics. One sample T Tests will be used to assess change scores from baseline to post-intervention.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/05/2022
Actual
10/08/2022
Date of last participant enrolment
Anticipated
25/10/2022
Actual
14/02/2023
Date of last data collection
Anticipated
25/11/2022
Actual
28/02/2023
Sample size
Target
50
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311106 0
University
Name [1] 311106 0
Monash University
Country [1] 311106 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Alliance Lane, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 312437 0
None
Name [1] 312437 0
Address [1] 312437 0
Country [1] 312437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310636 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310636 0
Ethics committee country [1] 310636 0
Australia
Date submitted for ethics approval [1] 310636 0
29/06/2021
Approval date [1] 310636 0
10/08/2021
Ethics approval number [1] 310636 0
26268

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118346 0
Dr Nicole Robinson
Address 118346 0
Monash University, 18 Alliance Lane and 18 Innovation Walk, Clayton Campus, VIC 3800, Australia
Country 118346 0
Australia
Phone 118346 0
+61 0399058933
Fax 118346 0
Email 118346 0
nicole.robinson@monash.edu
Contact person for public queries
Name 118347 0
Nicole Robinson
Address 118347 0
Monash University, 18 Alliance Lane and 18 Innovation Walk, Clayton Campus, VIC 3800, Australia
Country 118347 0
Australia
Phone 118347 0
+61 0399058933
Fax 118347 0
Email 118347 0
nicole.robinson@monash.edu
Contact person for scientific queries
Name 118348 0
Nicole Robinson
Address 118348 0
Monash University, 18 Alliance Lane and 18 Innovation Walk, Clayton Campus, VIC 3800, Australia
Country 118348 0
Australia
Phone 118348 0
+61 0399058933
Fax 118348 0
Email 118348 0
nicole.robinson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.